Dear Jing,
it is a clear A)! If you have only a single set of specification it has to
be applied both for release and end of shelf life.
Kind Regards / Mit freundlichen Grüssen
*Dr. Joachim Lutz*
F. Hoffmann - La Roche AG
PTDCD
Bldg. 64/325
CH - 4070 Basel
Phone: +41 61 68 88348
Fax: +41 61 68 70280
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On Fri, Mar 17, 2017 at 3:46 PM, Capucao, Jing [MCCUS] <[log in to unmask]
> wrote:
> Dear Folks,
> This should be an easy one so please let me know your thoughts!
>
> If you have acceptance criteria or specifications that are not indicated
> as either "for release only" or "for stability only", for example:
>
> Active Assay: 90.0-110.0%
> Unspecified Degradation Products: Not More Than 0.2%
> Moisture: Maximum 5%
>
> Do the specifications apply:
>
> A: for both release and stability?
> B: for stability only?
> C: other, please specify...
>
> Thank you in advance for your responses!
> Jing
>
>
> Jing Capucao, Ph. D.
> R&D Stability Manager
> Johnson & Johnson Consumer Inc.
> [log in to unmask]
> 215-273-2441
>
>
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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
Avista Pharma Solutions - http://www.avistapharma.com/
Comprehensive testing and CMC services organization
Analytical and Microbiology support to early stage API and drug product development and manufacturing.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop, reach in to walk-in
rooms along with chambers for freeze/thaw, temperature cycling applications.
|
